SECTIONS 1200-1214 - California Statutes

BUSINESS AND PROFESSIONS CODE

SECTION 1200-1214

1200. Every provision of this chapter shall be liberally construed
to protect the interests of all persons affected.

1201. As used in this chapter, "person" includes firm, association,
partnership, individual, limited liability company, and corporation.

1202. As used in this chapter, "department" means the State
Department of Health Services.

1202.5. (a) For purposes of this chapter "CLIA" means the federal
Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec.
263a; P.L. 100-578) and the regulations adopted thereunder by the
federal Health Care Financing Administration and effective on January
1, 1994, or any later date, when adopted in California pursuant to
subdivision (b) of Section 1208.
(b) For purposes of this chapter "HCFA" means the Health Care
Financing Administration of the federal Department of Health and
Human Services.

1203. As used in this chapter, "clinical laboratory bioanalyst" or
"bioanalyst" means a person licensed under Section 1260 to engage in
clinical laboratory practice and direction of a clinical laboratory.
A person licensed as a clinical laboratory bioanalyst or bioanalyst
and qualified under CLIA may perform clinical laboratory tests or
examinations classified as of high complexity under CLIA and the
duties and responsibilities of a laboratory director, technical
consultant, clinical consultant, technical supervisor, and general
supervisor, as specified under CLIA, in the specialties of
histocompatibility, microbiology, diagnostic immunology, chemistry,
hematology, immunohematology, genetics, or other specialty or
subspecialty specified in regulations adopted by the department. A
person licensed as a clinical laboratory bioanalyst or bioanalyst may
perform any clinical laboratory test or examination classified as
waived or of moderate complexity under CLIA.

1204. As used in this chapter, "clinical laboratory scientist"
means any person other than a licensed clinical laboratory bioanalyst
or trainee who is licensed under Sections 1261 and 1262 to engage in
clinical laboratory practice under the overall operation and
administration of a laboratory director. A person licensed as a
clinical laboratory scientist and qualified under CLIA may perform
clinical laboratory tests or examinations classified as of high
complexity under CLIA and the duties and responsibilities of a
technical consultant, clinical consultant, technical supervisor, and
general supervisor, as specified under CLIA, in the specialties of
histocompatibility, microbiology, diagnostic immunology, chemistry,
hematology, immunohematology, genetics, or other specialty or
subspecialty specified by regulation adopted by the department. A
person licensed as a "clinical laboratory scientist" may perform any
clinical laboratory test or examination classified as waived or of
moderate complexity under CLIA.

1205. As used in this chapter, "trainee" means any person licensed
under this chapter for the purpose of receiving comprehensive
practical experience and instruction in clinical laboratory
procedures in one of the sciences or in general clinical laboratory
science under the direct and responsible supervision of a person
authorized to direct a laboratory under the provisions of this
chapter, clinical laboratory scientist, clinical chemist scientist,
clinical microbiologist scientist, clinical toxicologist scientist,
clinical immunohematologist scientist, clinical genetic molecular
biologist scientist, clinical cytogeneticist scientist, clinical
histocompatibility scientist, or other equivalent licensee in the
science or specialty or subspecialty for which he or she is licensed
in a clinical laboratory certified for this purpose by the department
under this chapter.

1206. (a) For the purposes of this chapter the following
definitions are applicable:
(1) "Biological specimen" means any material that is derived from
the human body.
(2) "Blood electrolyte analysis" means the measurement of
electrolytes in a blood specimen by means of ion selective electrodes
on instruments specifically designed and manufactured for blood gas
and acid-base analysis.
(3) "Blood gas analysis" means a clinical laboratory test or
examination that deals with the uptake, transport, and metabolism of
oxygen and carbon dioxide in the human body.
(4) "Clinical laboratory test or examination" means the detection,
identification, measurement, evaluation, correlation, monitoring,
and reporting of any particular analyte, entity, or substance within
a biological specimen for the purpose of obtaining scientific data
which may be used as an aid to ascertain the presence, progress, and
source of a disease or physiological condition in a human being, or
used as an aid in the prevention, prognosis, monitoring, or treatment
of a physiological or pathological condition in a human being, or
for the performance of nondiagnostic tests for assessing the health
of an individual.
(5) "Clinical laboratory science" means any of the sciences or
scientific disciplines used to perform a clinical laboratory test or
examination.
(6) "Clinical laboratory practice" means the application of
clinical laboratory sciences or the use of any means that applies the
clinical laboratory sciences within or outside of a licensed or
registered clinical laboratory. Clinical laboratory practice includes
consultation, advisory, and other activities inherent to the
profession.
(7) "Clinical laboratory" means any place used, or any
establishment or institution organized or operated, for the
performance of clinical laboratory tests or examinations or the
practical application of the clinical laboratory sciences. That
application may include any means that applies the clinical
laboratory sciences.
(8) "Direct and constant supervision" means personal observation
and critical evaluation of the activity of unlicensed laboratory
personnel by a physician and surgeon, or by a person licensed under
this chapter other than a trainee, during the entire time that the
unlicensed laboratory personnel are engaged in the duties specified
in Section 1269.
(9) "Location" means either a street and city address, or a site
or place within a street and city address, where any of the clinical
laboratory sciences or scientific disciplines are practiced or
applied, or where any clinical laboratory tests or examinations are
performed.
(10) "Physician office laboratory" means a clinical laboratory
that is licensed or registered under Section 1265, and that is
either: (A) a clinical laboratory that is owned and operated by a
partnership or professional corporation that performs clinical
laboratory tests or examinations only for patients of five or fewer
physicians and surgeons or podiatrists who are shareholders,
partners, or employees of the partnership or professional corporation
that owns and operates the clinical laboratory; or (B) a clinical
laboratory that is owned and operated by an individual licensed
physician and surgeon or a podiatrist, and that performs clinical
laboratory tests or examinations only for patients of the physician
and surgeon or podiatrist who owns and operates the clinical
laboratory.
(11) "Public health laboratory" means a laboratory that is
operated by a city or county in conformity with Article 5 (commencing
with Section 101150) of Chapter 2 of Part 3 of Division 101 of the
Health and Safety Code and the regulations adopted thereunder.
(12) "Specialty" means histocompatibility, microbiology,
diagnostic immunology, chemistry, hematology, immunohematology,
pathology, genetics, or other specialty specified by regulation
adopted by the department.
(13) "Subspecialty" for purposes of microbiology, means
bacteriology, mycobacteriology, mycology, parasitology, virology,
molecular biology, and serology for diagnosis of infectious diseases,
or other subspecialty specified by regulation adopted by the
department; for purposes of diagnostic immunology, means syphilis
serology, general immunology, or other subspecialty specified by
regulation adopted by the department; for purposes of chemistry,
means routine chemistry, clinical microscopy, endocrinology,
toxicology, or other subspecialty specified by regulation adopted by
the department; for purposes of immunohematology, means ABO/Rh Type
and Group, antibody detection for transfusion, antibody detection
nontransfusion, antibody identification, compatibility, or other
subspecialty specified by regulation adopted by the department; for
pathology, means tissue pathology, oral pathology, diagnostic
cytology, or other subspecialty specified by regulation adopted by
the department; for purposes of genetics, means molecular biology
related to the diagnosis of human genetic abnormalities,
cytogenetics, or other subspecialty specified by regulation adopted
by the department.
(14) "Direct and responsible supervision" means both of the
following:
(A) Personal observation and critical evaluation of the activity
of a trainee by a physician and surgeon, or by a person licensed
under this chapter other than a trainee, during the entire time that
the trainee is performing clinical laboratory tests or examinations.
(B) Personal review by the physician and surgeon or the licensed
person of all results of clinical laboratory testing or examination
performed by the trainee for accuracy, reliability, and validity
before the results are reported from the laboratory.
(15) "Licensed laboratory" means a clinical laboratory licensed
pursuant to paragraph (1) of subdivision (a) of Section 1265.
(16) "Registered laboratory" means a clinical laboratory
registered pursuant to paragraph (2) of subdivision (a) of Section
1265.
(17) "Point-of-care laboratory testing device" means a portable
laboratory testing instrument to which the following applies:
(A) It is used within the proximity of the patient for whom the
test or examination is being conducted.
(B) It is used in accordance with the patient test management
system, the quality control program, and the comprehensive quality
assurance program established and maintained by the laboratory
pursuant to paragraph (2) of subdivision (d) of Section 1220.
(C) It meets the following criteria:
(i) Performs clinical laboratory tests or examinations classified
as waived or of moderate complexity under CLIA.
(ii) Performs clinical laboratory tests or examinations on
biological specimens that require no preparation after collection.
(iii) Provides clinical laboratory tests or examination results
without calculation or discretionary intervention by the testing
personnel.
(iv) Performs clinical laboratory tests or examinations without
the necessity for testing personnel to perform calibration or
maintenance, except resetting pursuant to the manufacturer's
instructions or basic cleaning.
(18) "Analyte" means the substance or constituent being measured
including, but not limited to, glucose, sodium, or theophyline, or
any substance or property whose presence or absence, concentration,
activity, intensity, or other characteristics are to be determined.
(b) Nothing in this chapter shall restrict, limit, or prevent any
person licensed to provide health care services under the laws of
this state, including, but not limited to, licensed physicians and
surgeons and registered nurses, from practicing the profession or
occupation for which he or she is licensed.
(c) Nothing in this chapter shall authorize any person to perform
or order health care services, or utilize the results of the clinical
laboratory test or examination, unless the person is otherwise
authorized to provide that care or utilize the results. The inclusion
of a person in Section 1206.5 for purposes of performing a clinical
laboratory test or examination shall not be interpreted to authorize
a person, who is not otherwise authorized, to perform venipuncture,
arterial puncture, or skin puncture.

1206.5. (a) Notwithstanding subdivision (b) of Section 1206 and
except as otherwise provided in Section 1241, no person shall perform
a clinical laboratory test or examination classified as waived under
CLIA unless the clinical laboratory test or examination is performed
under the overall operation and administration of the laboratory
director, as described in Section 1209, including, but not limited
to, documentation by the laboratory director of the adequacy of the
qualifications and competency of the personnel, and the test is
performed by any of the following persons:
(1) A licensed physician and surgeon holding a M.D. or D.O.
degree.
(2) A licensed podiatrist, a licensed dentist, or a licensed
naturopathic doctor, if the results of the tests can be lawfully
utilized within his or her practice.
(3) A person licensed under this chapter to engage in clinical
laboratory practice or to direct a clinical laboratory.
(4) A person authorized to perform tests pursuant to a certificate
issued under Article 5 (commencing with Section 101150) of Chapter 2
of Part 3 of Division 101 of the Health and Safety Code.
(5) A licensed physician assistant if authorized by a supervising
physician and surgeon in accordance with Section 3502 or 3535.
(6) A person licensed under Chapter 6 (commencing with Section
2700).
(7) A person licensed under Chapter 6.5 (commencing with Section
2840).
(8) A perfusionist if authorized by and performed in compliance
with Section 2590.
(9) A respiratory care practitioner if authorized by and performed
in compliance with Chapter 8.3 (commencing with Section 3700).
(10) A medical assistant, as defined in Section 2069, if the
waived test is performed pursuant to a specific authorization meeting
the requirements of Section 2069.
(11) A pharmacist, as defined in Section 4036, if ordering drug
therapy-related laboratory tests in compliance with clause (ii) of
subparagraph (A) of paragraph (5) of, or subparagraph (B) of
paragraph (4) of, subdivision (a) of Section 4052, or if performing
skin puncture in the course of performing routine patient assessment
procedures in compliance with Section 4052.1.
(12) A naturopathic assistant, as defined in Sections 3613 and
3640.2, if the waived test is performed pursuant to a specific
authorization meeting the requirements of Sections 3613 and 3640.2.
(13) Other health care personnel providing direct patient care.
(14) Any other person performing nondiagnostic testing pursuant to
Section 1244.
(b) Notwithstanding subdivision (b) of Section 1206, no person
shall perform clinical laboratory tests or examinations classified as
of moderate complexity under CLIA unless the clinical laboratory
test or examination is performed under the overall operation and
administration of the laboratory director, as described in Section
1209, including, but not limited to, documentation by the laboratory
director of the adequacy of the qualifications and competency of the
personnel, and the test is performed by any of the following persons:
(1) A licensed physician and surgeon holding a M.D. or D.O.
degree.
(2) A licensed podiatrist or a licensed dentist if the results of
the tests can be lawfully utilized within his or her practice.
(3) A person licensed under this chapter to engage in clinical
laboratory practice or to direct a clinical laboratory.
(4) A person authorized to perform tests pursuant to a certificate
issued under Article 5 (commencing with Section 101150) of Chapter 2
of Part 3 of Division 101 of the Health and Safety Code.
(5) A licensed physician assistant if authorized by a supervising
physician and surgeon in accordance with Section 3502 or 3535.
(6) A person licensed under Chapter 6 (commencing with Section
2700).
(7) A perfusionist if authorized by and performed in compliance
with Section 2590.
(8) A respiratory care practitioner if authorized by and performed
in compliance with Chapter 8.3 (commencing with Section 3700).
(9) A person performing nuclear medicine technology if authorized
by and performed in compliance with Article 6 (commencing with
Section 107150) of Chapter 4 of Part 1 of Division 104 of the Health
and Safety Code.
(10) Any person if performing blood gas analysis in compliance
with Section 1245.
(11) (A) A person certified or licensed as an "Emergency Medical
Technician II" or paramedic pursuant to Division 2.5 (commencing with
Section 1797) of the Health and Safety Code while providing
prehospital medical care, a person licensed as a psychiatric
technician under Chapter 10 (commencing with Section 4500) of
Division 2, as a vocational nurse pursuant to Chapter 6.5 (commencing
with Section 2840), or as a midwife licensed pursuant to Article 24
(commencing with Section 2505) of Chapter 5, or certified by the
department pursuant to Division 5 (commencing with Section 70001) of
Title 22 of the California Code of Regulations as a nurse assistant
or a home health aide, who provides direct patient care, if the
person is performing the test as an adjunct to the provision of
direct patient care by the person, is utilizing a point-of-care
laboratory testing device at a site for which a laboratory license or
registration has been issued, meets the minimum clinical laboratory
education, training, and experience requirements set forth in
regulations adopted by the department, and has demonstrated to the
satisfaction of the laboratory director that he or she is competent
in the operation of the point-of-care laboratory testing device for
each analyte to be reported.
(B) Prior to being authorized by the laboratory director to
perform laboratory tests or examinations, testing personnel
identified in subparagraph (A) shall participate in a preceptor
program until they are able to perform the clinical laboratory tests
or examinations authorized in this section with results that are
deemed accurate and skills that are deemed competent by the
preceptor. For the purposes of this section, a "preceptor program"
means an organized system that meets regulatory requirements in which
a preceptor provides and documents personal observation and critical
evaluation, including review of accuracy, reliability, and validity,
of laboratory testing performed.
(12) Any other person within a physician office laboratory if the
test is performed under the supervision of the patient's physician
and surgeon or podiatrist who shall be accessible to the laboratory
to provide onsite, telephone, or electronic consultation as needed,
and shall: (A) ensure that the person is performing test methods as
required for accurate and reliable tests; and (B) have personal
knowledge of the results of the clinical laboratory testing or
examination performed by that person before the test results are
reported from the laboratory.
(13) A pharmacist, if ordering drug therapy-related laboratory
tests in compliance with clause (ii) of subparagraph (A) of paragraph
(5) of, or subparagraph (B) of paragraph (4) of, subdivision (a) of
Section 4052.
(c) Notwithstanding subdivision (b) of Section 1206, no person
shall perform clinical laboratory tests or examinations classified as
of high complexity under CLIA unless the clinical laboratory test or
examination is performed under the overall operation and
administration of the laboratory director, as described in Section
1209, including, but not limited to, documentation by the laboratory
director of the adequacy of the qualifications and competency of the
personnel, and the test is performed by any of the following persons:
(1) A licensed physician and surgeon holding a M.D. or D.O.
degree.
(2) A licensed podiatrist or a licensed dentist if the results of
the tests can be lawfully utilized within his or her practice.
(3) A person licensed under this chapter to engage in clinical
laboratory practice or to direct a clinical laboratory if the test or
examination is within a specialty or subspecialty authorized by the
person's licensure.
(4) A person authorized to perform tests pursuant to a certificate
issued under Article 5 (commencing with Section 101150) of Chapter 2
of Part 3 of Division 101 of the Health and Safety Code if the test
or examination is within a specialty or subspecialty authorized by
the person's certification.
(5) A licensed physician assistant if authorized by a supervising
physician and surgeon in accordance with Section 3502 or 3535.
(6) A perfusionist if authorized by and performed in compliance
with Section 2590.
(7) A respiratory care practitioner if authorized by and performed
in compliance with Chapter 8.3 (commencing with Section 3700).
(8) A person performing nuclear medicine technology if authorized
by and performed in compliance with Article 6 (commencing with
Section 107150) of Chapter 4 of Part 1 of Division 104 of the Health
and Safety Code.
(9) Any person if performing blood gas analysis in compliance with
Section 1245.
(10) Any other person within a physician office laboratory if the
test is performed under the onsite supervision of the patient's
physician and surgeon or podiatrist who shall: (A) ensure that the
person is performing test methods as required for accurate and
reliable tests; and (B) have personal knowledge of the results of
clinical laboratory testing or examination performed by that person
before the test results are reported from the laboratory.
(d) Clinical laboratory examinations classified as
provider-performed microscopy under CLIA may be personally performed
using a brightfield or phase/contrast microscope by one of the
following practitioners:
(1) A licensed physician and surgeon using the microscope during
the patient's visit on a specimen obtained from his or her own
patient or from a patient of a group medical practice of which the
physician is a member or employee.
(2) A nurse midwife holding a certificate as specified by Section
2746.5, a licensed nurse practitioner as specified in Section 2835.5,
or a licensed physician assistant acting under the supervision of a
physician pursuant to Section 3502 using the microscope during the
patient's visit on a specimen obtained from his or her own patient or
from the patient of a clinic, group medical practice, or other
health care provider of which the certified nurse midwife, licensed
nurse practitioner, or licensed physician assistant is an employee.
(3) A licensed dentist using the microscope during the patient's
visit on a specimen obtained from his or her own patient or from a
patient of a group dental practice of which the dentist is a member
or an employee.

1207. (a) As used in this chapter, "clinical chemist," or "clinical
microbiologist," or "clinical toxicologist," or "clinical genetic
molecular biologist," or "clinical cytogeneticist," or "oral and
maxillofacial pathologist" means any person licensed by the
department under Section 1264 to engage in, or supervise others
engaged in, clinical laboratory practice limited to his or her area
of specialization or to direct a clinical laboratory, or portion
thereof, limited to his or her area of specialization. Such a
licensed person who is qualified under CLIA may perform clinical
laboratory tests or examinations classified as of high complexity
under CLIA, and the duties and responsibilities of a laboratory
director, technical consultant, clinical consultant, technical
supervisor, and general supervisor, as specified under CLIA, limited
to his or her area of specialty or subspecialty as described in
subdivision (b), and shall only direct a clinical laboratory
providing service within those specialties or subspecialties. A
person licensed as a "clinical chemist," or "clinical microbiologist,"
or "clinical toxicologist," or "clinical genetic molecular
biologist," or "clinical cytogeneticist," or "oral and maxillofacial
pathologist" may perform any clinical laboratory test or examination
classified as waived or of moderate complexity under CLIA.
(b) The specialty or subspecialty for each of the limited license
categories identified in subdivision (a), and the clinical
laboratories that may be directed by persons licensed in each of
those categories, are the following:
(1) For a person licensed under this chapter as a clinical
chemist, the specialty of chemistry and the subspecialties of routine
chemistry, endocrinology, clinical microscopy, toxicology, or other
specialty or subspecialty specified by regulation adopted by the
department.
(2) For a person licensed under this chapter as a clinical
microbiologist, the specialty of microbiology and the subspecialties
of bacteriology, mycobacteriology, mycology, parasitology, virology,
molecular biology, and serology for diagnosis of infectious diseases,
or other specialty or subspecialty specified by regulation adopted
by the department.
(3) For a person licensed under this chapter as a clinical
toxicologist, the subspecialty of toxicology within the specialty of
chemistry or other specialty or subspecialty specified by regulation
adopted by the department.
(4) For a person licensed under this chapter as a clinical genetic
molecular biologist, the subspecialty of molecular biology related
to diagnosis of human genetic abnormalities within the specialty of
genetics or other specialty or subspecialty specified by regulation
adopted by the department.
(5) For a person licensed under this chapter as a clinical
cytogeneticist, the subspecialty of cytogenetics within the specialty
of genetics or other specialty or subspecialty specified by
regulation adopted by the department.
(6) For a person licensed under this chapter as an oral and
maxillofacial pathologist, the subspecialty of oral pathology within
the specialty of pathology or other specialty or subspecialty
specified by regulation adopted by the department.

1208. (a) For the purposes of this chapter whenever the department
determines that a new category of license is necessary, either to
direct a laboratory, or to perform clinical laboratory tests or
examinations in specific specialties or subspecialties, or that the
specialties or subspecialties authorized under an existing license
category should be modified, it shall adopt regulations identifying
the license category or modification, the education, training, and
examination necessary to obtain the license, and the specialty or
subspecialty, or both, included within the new license category, or
within the existing category as modified.
(b) Any CLIA regulation adopted by HCFA as a final rule after
January 1, 1994, shall be evaluated by the department in consultation
with the multidisciplinary committee appointed pursuant to Section
1228. Any new federal regulation that is deemed by the department to
be equivalent to or more stringent than California laws or
regulations, shall become effective by operation of law as a
regulation adopted under this chapter, 90 days after adoption by HCFA
and the department publishes the notice required by subdivision (c),
or on January 1, 1996, whichever is later. After publishing the
notice required by subdivision (c), any new federal regulation deemed
by the department to be less stringent than current California law
or regulation shall be noticed by the department as a comparable
state regulation for a rulemaking proceeding in accordance with
Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3
of Title 2 of the Government Code, which shall result in the
adoption, amendment, or rejection of that noticed state regulation.
(c) The department shall publish a notice in the California
Regulatory Notice Register indicating that a CLIA regulation has been
adopted by HCFA as a final rule. The notice shall include the
citation to the Federal Register or the Code of Federal Regulations
for the CLIA regulation. The notice shall also include the department'
s determination regarding whether the regulation is more stringent,
equivalent to, or less stringent than current California law or
regulation.

1209. (a) As used in this chapter, "laboratory director" means any
person who is a duly licensed physician and surgeon, or, only for
purposes of a clinical laboratory test or examination classified as
waived, is a duly licensed naturopathic doctor, or is licensed to
direct a clinical laboratory under this chapter and who substantially
meets the laboratory director qualifications under CLIA for the type
and complexity of tests being offered by the laboratory. The
laboratory director, if qualified under CLIA, may perform the duties
of the technical consultant, technical supervisor, clinical
consultant, general supervisor, and testing personnel, or delegate
these responsibilities to persons qualified under CLIA. If the
laboratory director reapportions performance of those
responsibilities or duties, he or she shall remain responsible for
ensuring that all those duties and responsibilities are properly
performed.
(b) (1) The laboratory director is responsible for the overall
operation and administration of the clinical laboratory, including
administering the technical and scientific operation of a clinical
laboratory, the selection and supervision of procedures, the
reporting of results, and active participation in its operations to
the extent necessary to ensure compliance with this act and CLIA. He
or she shall be responsible for the proper performance of all
laboratory work of all subordinates and shall employ a sufficient
number of laboratory personnel with the appropriate education and
either experience or training to provide appropriate consultation,
properly supervise and accurately perform tests, and report test
results in accordance with the personnel qualifications, duties, and
responsibilities described in CLIA and this chapter.
(2) Where a point-of-care laboratory testing device is utilized
and provides results for more than one analyte, the testing personnel
may perform and report the results of all tests ordered for each
analyte for which he or she has been found by the laboratory director
to be competent to perform and report.
(c) As part of the overall operation and administration, the
laboratory director of a registered laboratory shall document the
adequacy of the qualifications (educational background, training, and
experience) of the personnel directing and supervising the
laboratory and performing the laboratory test procedures and
examinations. In determining the adequacy of qualifications, the
laboratory director shall comply with any regulations adopted by the
department that specify the minimum qualifications for personnel, in
addition to any CLIA requirements relative to the education or
training of personnel.
(d) As part of the overall operation and administration, the
laboratory director of a licensed laboratory shall do all of the
following:
(1) Ensure that all personnel, prior to testing biological
specimens, have the appropriate education and experience, receive the
appropriate training for the type and complexity of the services
offered, and have demonstrated that they can perform all testing
operations reliably to provide and report accurate results. In
determining the adequacy of qualifications, the laboratory director
shall comply with any regulations adopted by the department that
specify the minimum qualifications for, and the type of procedures
that may be performed by, personnel in addition to any CLIA
requirements relative to the education or training of personnel. Any
regulations adopted pursuant to this section that specify the type of
procedure that may be performed by testing personnel shall be based
on the skills, knowledge, and tasks required to perform the type of
procedure in question.
(2) Ensure that policies and procedures are established for
monitoring individuals who conduct preanalytical, analytical, and
postanalytical phases of testing to ensure that they are competent
and maintain their competency to process biological specimens,
perform test procedures, and report test results promptly and
proficiently, and, whenever necessary, identify needs for remedial
training or continuing education to improve skills.
(3) Specify in writing the responsibilities and duties of each
individual engaged in the performance of the preanalytic, analytic,
and postanalytic phases of clinical laboratory tests or examinations,
including which clinical laboratory tests or examinations the
individual is authorized to perform, whether supervision is required
for the individual to perform specimen processing, test performance,
or results reporting, and whether consultant, supervisor, or director
review is required prior to the individual reporting patient test
results.
(e) The competency and performance of staff of a licensed
laboratory shall be evaluated and documented by the laboratory
director, or by a person who qualifies as a technical consultant or a
technical supervisor under CLIA depending on the type and complexity
of tests being offered by the laboratory.
(1) The procedures for evaluating the competency of the staff
shall include, but are not limited to, all of the following:
(A) Direct observations of routine patient test performance,
including patient preparation, if applicable, and specimen handling,
processing, and testing.
(B) Monitoring the recording and reporting of test results.
(C) Review of intermediate test results or worksheets, quality
control records, proficiency testing results, and preventive
maintenance records.
(D) Direct observation of performance of instrument maintenance
and function checks.
(E) Assessment of test performance through testing previously
analyzed specimens, internal blind testing samples, or external
proficiency testing samples.
(F) Assessment of problem solving skills.
(2) Evaluation and documentation of staff competency and
performance shall occur at least semiannually during the first year
an individual tests biological specimens. Thereafter, evaluations
shall be performed at least annually unless test methodology or
instrumentation changes, in which case, prior to reporting patient
test results, the individual's performance shall be reevaluated to
include the use of the new test methodology or instrumentation.
(f) The laboratory director of each clinical laboratory of an
acute care hospital shall be a physician and surgeon who is a
qualified pathologist, except as follows:
(1) If a qualified pathologist is not available, a physician and
surgeon or a clinical laboratory bioanalyst qualified as a laboratory
director under subdivision (a) may direct the laboratory. However, a
qualified pathologist shall be available for consultation at
suitable intervals to ensure high quality service.
(2) If there are two or more clinical laboratories of an acute
care hospital, those additional clinical laboratories that are
limited to the performance of blood gas analysis, blood electrolyte
analysis, or both, may be directed by a physician and surgeon
qualified as a laboratory director under subdivision (a),
irrespective of whether a pathologist is available.
As used in this subdivision, a qualified pathologist is a
physician and surgeon certified or eligible for certification in
clinical or anatomical pathology by the American Board of Pathology
or the American Osteopathic Board of Pathology.
(g) Subdivision (f) does not apply to any director of a clinical
laboratory of an acute care hospital acting in that capacity on or
before January 1, 1988.
(h) A laboratory director may serve as the director of up to the
maximum number of laboratories stipulated by CLIA, as defined under
Section 1202.5.

1209.1. (a) As used in this chapter, "histocompatibility laboratory
director" means a physician and surgeon licensed to practice
medicine pursuant to Chapter 5 (commencing with Section 2000) who is
qualified pursuant to Section 1209, a bioanalyst licensed pursuant to
Section 1260 who is qualified pursuant to Sections 1203 and 1209, or
a person who has earned a doctoral degree in a biological science,
who has completed, subsequent to graduation, four years of experience
in immunology, two of which have been in histocompatibility testing.
(b) On and after January 1, 2007, in order to be eligible for
licensure as a histocompatibility laboratory director, an applicant
who is not a duly licensed physician and surgeon or a duly licensed
bioanalyst shall provide evidence of satisfactory performance on a
written examination in histocompatibility administered by the
American Board of Histocompatibility and Immunogenetics, and have
demonstrated satisfactory performance on an oral examination
administered by the department regarding this chapter and Part 493
(commencing with Section 493.1) of Subchapter G of Chapter IV of
Title 42 of the Code of Federal Regulations.
(c) A person licensed under Section 1260.1 as a histocompatibility
laboratory director and qualified under CLIA may perform clinical
laboratory tests or examinations classified as of high complexity
under CLIA and the duties and responsibilities of a laboratory
director, technical consultant, clinical consultant, technical
supervisor, and general supervisor, as specified under CLIA, in the
specialty of histocompatibility, immunology, or other specialty or
subspecialty specified by regulation adopted by the department. A
person licensed as a "histocompatibility laboratory director" may
perform any clinical laboratory test or examination classified as
waived or of moderate complexity under CLIA.

1209.5. (a) "Autoverification" means the use of a computer
algorithm in conjunction with automated clinical laboratory
instrumentation to review and verify the results of a clinical
laboratory test or examination for accuracy and reliability.
(b) The laboratory director or authorized designee shall
establish, validate, and document explicit criteria by which the
clinical laboratory test or examination results are autoverified.
(c) The laboratory director or authorized designee shall annually
revalidate the explicit criteria by which the clinical laboratory
test or examination results are autoverified. The laboratory director
shall approve and annually reapprove the computer algorithm.
(d) An authorized designee may be appointed by the laboratory
director for the purposes of this section. The authorized designee
shall be licensed to engage in clinical laboratory practice pursuant
to this chapter and shall be qualified as a clinical consultant,
technical supervisor, general supervisor, or technical consultant
pursuant to regulations adopted by the department.
(e) A person licensed to perform the applicable type and
complexity of testing pursuant to Section 1206.5 shall be physically
present onsite in the clinical laboratory and shall have documented
competency pursuant to Section 1209 in all tests being autoverified,
and shall be responsible for the accuracy and reliability of the
results of the clinical laboratory test or examination when the
results are autoverified and reported.

1210. (a) As used in this chapter, "clinical chemist scientist,"
"clinical microbiologist scientist," "clinical toxicologist
scientist," "clinical immunohematologist scientist," "clinical
genetic molecular biologist scientist," "clinical cytogeneticist
scientist," and "clinical histocompatibility scientist" means any
person, other than a person licensed to direct a clinical laboratory,
or licensed as a clinical laboratory scientist or trainee, who is
licensed under Sections 1261, 1261.5, and 1262 to engage in clinical
laboratory practice. Such a licensed person who is qualified under
CLIA may perform clinical laboratory tests classified as of high
complexity under CLIA and the duties and responsibilities of a
technical consultant, clinical consultant, technical supervisor, and
general supervisor limited to the specialty or subspecialty as
identified in subdivision (b) for which he or she is licensed by the
department. A person licensed as a "clinical chemist scientist," or
"clinical microbiologist scientist," or "clinical toxicologist
scientist," or "clinical immunohematologist scientist," or "clinical
genetic molecular biologist scientist," or "clinical cytogeneticist
scientist," or a "clinical histocompatibility scientist" may perform
any clinical laboratory test or examination classified as waived or
of moderate complexity under CLIA.
(b) The specialties and subspecialties included in each of the
license categories identified in subdivision (a), are the following:
(1) For a person licensed under this chapter as a clinical chemist
scientist, the specialty of chemistry and the subspecialties of
routine chemistry, endocrinology, clinical microscopy, toxicology, or
other specialty or subspecialty specified by regulation adopted by
the department.
(2) For a person licensed under this chapter as a clinical
microbiologist scientist, the specialty of microbiology and the
subspecialties of bacteriology, mycobacteriology, mycology,
parasitology, virology, or molecular biology and serology for
diagnosis of infectious diseases, or other specialty or subspecialty
specified by regulation adopted by the department.
(3) For a person licensed under this chapter as a clinical
toxicologist scientist, the subspecialty of toxicology within the
specialty of chemistry or other specialty or subspecialty specified
by regulation adopted by the department.
(4) For a person licensed under this chapter as a clinical genetic
molecular biologist scientist, the subspecialty of molecular biology
related to the diagnosis of human genetic abnormalities within the
specialty of genetics, or other specialty or subspecialty specified
by regulation adopted by the department.
(5) For a person licensed under this chapter as a clinical
cytogeneticist scientist, the subspecialty of cytogenetics within the
specialty of genetics or other specialty or subspecialty specified
by regulation adopted by the department.
(6) For a person licensed under this chapter as a clinical
immunohematologist scientist, the specialty of immunohematology or
other specialty or subspecialty specified by regulation adopted by
the department.
(7) For a person licensed under this chapter as a clinical
histocompatibility scientist, the specialty of histocompatibility or
other specialty or subspecialty specified by regulation adopted by
the department.
(c) Clinical chemist scientists, clinical microbiologist
scientists, clinical toxicologist scientists, clinical
immunohematologist scientists, clinical genetic molecular biologist
scientists, clinical cytogeneticist scientists, and clinical
histocompatibility scientists shall engage in clinical laboratory
practice authorized by their licensure only under the overall
operation and administration of a laboratory director.

1211. (a) As used in this chapter, "owner" means any person with an
ownership or control interest in a clinical laboratory.
(b) "Person with an ownership or control interest" means a person,
partnership, or corporation that meets any of the following
descriptions:
(1) Has an ownership interest totaling 5 percent or more in a
clinical laboratory.
(2) Has an indirect ownership interest equal to 5 percent or more
in a clinical laboratory.
(3) Has a combination of direct and indirect ownership interests
equal to 5 percent or more in a clinical laboratory.
(4) Owns an interest of 5 percent or more in any mortgage, deed of
trust, note, or other obligation secured by the clinical laboratory
if that interest equals at least 5 percent of the value of the
property or assets of the clinical laboratory.
(5) Is an officer or director of a clinical laboratory that is
organized as a corporation.
(6) Is a partner in a clinical laboratory that is organized as a
partnership with no more than 25 partners, general or limited.
(7) Is a partner who exercises any operational or managerial
control over a clinical laboratory organized as a partnership with
more than 25 partners, general or limited.
(c) As used in this chapter "ownership interest" means the
possession of equity in capital, stock, or profits.
(d) "Indirect ownership interest" means an ownership interest in
an entity that has an ownership interest in a clinical laboratory,
and includes an ownership interest in any entity that has an indirect
ownership interest in a clinical laboratory.
(e) "Change in ownership" means any change in the persons who are
owners.
(f) "Major change in ownership" means a change in ownership where
50 percent or more of the ownership interest is owned by persons
other than the owners to whom the current clinical laboratory license
or registration is issued.
(g) "Change in name" means any change in the name under which the
laboratory operates or is doing business.
(h) "Change in location" means any change in the street and city
address, or the site or place within the street and city address, for
which a license or registration is issued.
(i) "Change in laboratory director" means any change in the
laboratory director or directors to whom the current license or
registration is issued.
(j) "Major change in laboratory directorship" means a change in
laboratory director or directors resulting in the situation where
less than 50 percent of the laboratory directors to whom the current
laboratory license or registration is issued remain after the change.

1211.5. For the purposes of this chapter, "cytological slides"
shall refer to cellular materials submitted for preliminary cytologic
examination.

1212. (a) As used in this chapter, "unlicensed laboratory personnel"
means a laboratory aide, histocompatibility technician,
cardiopulmonary technician, or other person performing the activities
authorized by Section 1269.
(b) Any person who is authorized under California law or
regulation to perform a clinical laboratory test or examination, or
to engage in clinical laboratory practice, shall not come within the
definition of "unlicensed laboratory personnel" when performing the
clinical laboratory test or examination or engaging in the clinical
laboratory practice authorized.

1213. As used in this chapter, "school" means any place,
establishment, or institution organized and operated to offer
training for one or more of the personnel classifications included in
this chapter or the regulations pertaining thereto.

1214. As used in this chapter, "health fair" means a program of
health assessment procedures offered to the general public that may
include screening, self-ordered, or diagnostic clinical laboratory
tests or examinations performed by a clinical laboratory licensed or
registered under subdivision (a) of Section 1265 that meets all the
requirements of this chapter.